Pharmacological delivery implement for use with cardiac repair devices

ABSTRACT

A pharmacological delivery implement for use with cardiac repair devices. The pharmacological delivery implement comprises a porous member defining an outer surface, an internal channel configured to selectively house a pharmacological agent, and a plurality of release holes each extending from the outer surface to the internal channel. Following implantation of the pharmacological delivery implement, at least a portion of the pharmacological agent exits the internal channel through the plurality of release holes.

BACKGROUND OF THE INVENTION

The present invention relates to a pharmacological delivery implement.More particularly, the present invention relates to a pharmacologicaldelivery implement for use with repair devices implantable within thecardiac system.

Cardiac repair devices, such as prosthetic valves, annuloplastyprosthesis, vascular grafts, etc., have conventionally been implantedinto the heart or surrounding vessels to repair or strengthen diseasedor ailing members of the cardiac system. However, many of the cardiacrepair devices include prosthetic materials that are not native to theinternal system of patients. As such, a patient often has an adversereaction to the implantation of non-native materials causing chronicinflammation and excessive scar tissue, i.e. pannus.

Various types of prosthetic heart valves, used to replace diseasednatural human heart valves, are known in the art. The actual shape andconfiguration of any particular prosthetic heart valve is, of course,dependent to some extent upon the valve being replaced (i.e. mitralvalve, tricuspid valve, aortic valve, and pulmonary valve). In generalterms, however, the prosthetic heart valve design attempts to replicatethe function of the heart valve being replaced and thus will includevalve leaflet-like structures. With this in mind, prosthetic heartvalves including valve leaflets are generally categorized as eitherforming relatively flexible leaflets or relatively rigid leaflets.

The category including prosthetic heart valves formed with relativelyflexible leaflets includes bioprosthetic heart valves having asubstantially annular, fabric-covered stent supporting a number ofleaflets made of a biological (e.g. porcine, pericardial tissue, etc.)or synthetic (e.g. polymeric) material. Prosthetic heart valvescategorized as forming relatively rigid leaflets include mechanicalprosthetic heart valves. A typical mechanical heart valve includes anannular valve housing or body to provide a passageway for blood flow.Relatively rigid leaflets are rotatably mounted to the annular housingand rotate to open or close the blood flow passageway.

Both flexible and rigid leaflet prosthetic heart valves typicallyinclude an annularly-extending, flexible sewing ring attached to thefabric-covered stent or valve housing, respectively. Upon implantationof the prosthetic heart valve, the sewing ring is attached to the heartvalve annulus surrounding the heart valve to be repaired, thereby,attaching the entirety of the prosthetic heart valve to the heart valveannulus.

During use of a prosthetic heart valve, inflammation can occur andfibrotic scar tissue may form. The fibrotic scar tissue can extend fromthe sewing ring to the valve leaflets, thereby, causing stenosis and/orregurgitation. Upon occurrence of any such problems, a prosthetic heartvalve is typically removed and replaced with a new prosthetic heartvalve. In particular, flexible leaflet prosthetic heart valvesexperiencing inflammation, stenosis, and/or regurgitation must beremoved in the relatively near future to prevent further harm to theheart valve and surrounding material.

Due to the mechanical attributes of the mechanical valve, a mechanicalvalve causing inflammation, stenosis, and/or regurgitation must beremoved almost immediately following detection of a problem in order toprevent dire consequences to the patient. Even if prosthetic valveremoval can be performed before such dire consequences occur, theremoval and replacement procedure once again exposes the patient to thegeneral dangers of surgery along with additional periods of heartstoppage. Due to the complicated nature of the heart vessel, it isdifficult to deliver pharmacological agents targeted to the heart valveannulus tissue to decrease inflammation, stenosis, regurgitation, etc.

Annuloplasty prosthesis, generally categorized as either annuloplastyrings or annuloplasty bands, are employed in conjunction with valvularreconstructive surgery to assist in the correction of heart valvedefects such as stenosis and valvular insufficiency. The purpose of theannuloplasty prosthesis is to restrict and/or support the heart valveannulus to correct and/or decrease valvular insufficiency. A posteriorportion of the annulus is often diseased or dilated and not wellsupported by heart tissue. An anterior portion of the annulus, incontrast, is well supported by surrounding heart tissue.

In general terms, annuloplasty rings completely encompass both theanterior and posterior portions of the valve annulus. Annuloplastybands, on the other hand, are specifically designed to primarilyencompass only a portion of the valve annulus. For example, anannuloplasty band may be configured to encompass only the posteriorportion of the valve annulus, thus promoting natural movement of theanterior portion of the heart valve annulus.

Inflammation and excessive scar tissue also typically form onannuloplasty prostheses causing similar problems as described above withrespect to prosthetic heart valves. Also similar as described above,annuloplasty prosthesis causing excessive inflammation or scar tissuetypically must be explanted and replaced, thereby, introducing thepatient to the dangers presented by additional surgeries includinganesthesia, infection, extended periods of heart stoppage, etc. Similarproblems, as those discussed above with respect to prosthetic heartvalves and annuloplasty prostheses, can be caused with other cardiacrepair devices such as vascular grafts, etc.

As described above, implantation of prosthetic heart valves,annuloplasty bands, and other cardiac repair devices may lead toexcessive inflammation, scar tissue, stenosis, and/or regurgitation. Assuch, a need exists for a cardiac repair device that prevents ordecreases the occurrence of inflammation, excessive scar tissue,stenosis, and/or regurgitation, thereby, decreasing the need forexplantation of the cardiac repair devices that, in turn, decreases thedangers to which a particular patient is exposed.

SUMMARY OF THE INVENTION

One aspect of the present invention relates to a pharmacologicaldelivery implement for use with cardiac repair devices. Thepharmacological delivery implement comprises a porous member defining anouter surface, an internal channel configured to selectively house apharmacological agent, and a plurality of release holes each extendingfrom the outer surface to the internal channel. Following implantationof the pharmacological delivery implement within the cardiac system, atleast a portion of the pharmacological agent exits the internal channelthrough the plurality of release holes.

Another aspect of the present invention relates to a cardiac repairdevice including a porous member and a fabric sheath. The porous memberdefines an outer surface, an internal channel, and a plurality ofrelease holes. The internal channel is configured to selectively house apharmacological agent. The plurality of release holes each extend fromthe outer surface to the internal channel. The fabric sheath encompassesthe porous member. Following implantation of the cardiac repair device,at least a portion of the pharmacological agent exits the internalchannel through the plurality of release holes.

Yet another aspect of the present invention relates to a method ofdelivering a pharmacological agent to cardiac tissue. The methodincludes providing a porous member defining an internal channelconfigured to selectively maintain a pharmacological agent, filling thechannel with a pharmacological agent, and implanting the porous memberfilled with the pharmacological agent within a cardiac system. Theporous member further defines an outer surface and a plurality ofrelease holes each extending from the outer surface to the internalchannel. Upon functioning of the cardiac system, at least a portion ofthe pharmacological agent exits the internal channel via the pluralityof release holes.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of one embodiment of a heart valveprosthesis incorporating a pharmacological delivery implement inaccordance with the present invention;

FIG. 2 is a top view of one embodiment of the pharmacological deliveryimplement of FIG. 1;

FIG. 2A is a cross-sectional view of the pharmacological deliveryimplement of FIG. 2 taken along the line 2A-2A;

FIG. 2B is a cross-sectional view of the pharmacological deliveryimplement of FIG. 2 taken along the line 2B-2B;

FIG. 3 is a side view of one embodiment of the heart valve prosthesis ofFIG. 1;

FIG. 4 is a perspective view of one embodiment of a heart valveprosthesis incorporating a pharmacological delivery implement inaccordance with the present invention;

FIG. 5 is a top view of one embodiment of an annuloplasty prosthesisincorporating a pharmacological delivery implement in accordance withthe present invention;

FIG. 5A is a cross-sectional view of one embodiment of the annuloplastyprosthesis of FIG. 5 taken along the line 5A-5A;

FIG. 5B is an alternate cross-sectional view of one embodiment of theannuloplasty prosthesis of FIG. 5 taken along the line 5A-5A;

FIG. 6 is a top view of the annuloplasty prosthesis of FIG. 5 mounted ona heart valve annulus;

FIG. 7 is a top view of one embodiment of an annuloplasty prosthesisincorporating a pharmacological delivery implement according to thepresent invention; and

FIG. 8 is a top view of one embodiment of an annuloplasty prosthesisincorporating a pharmacological delivery implement according to thepresent invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

One preferred embodiment of a heart valve prosthesis 10 incorporating apharmacological delivery implement 12 is illustrated in FIG. 1. Theheart valve prosthesis 10 generally includes a valve body 14 and asewing ring 16. In one embodiment, the heart valve prosthesis 10 is aflexible leaflet heart valve prosthesis 10. Valve body 14 includes astent 18 and leaflets 20. The stent 18 provides the support frameworkfor the heart valve prosthesis 10. The stent 18 includes an inner framemember or stent ring 22, which typically defines a circular or parabolicring, and stent posts 24. Each of the stent posts 24 extends from thestent ring 22 and terminates in a rounded tip or free end 26 oppositethe stent ring 22. The stent posts 24 are formed of a stiff butresiliently bendable material. Valve body 14 further includes a clothcover 28, which is preferably formed over the stent ring 22 and thestent posts 24. The cloth cover 28 is formed of a biocompatible, fabricmaterial.

Each of the leaflets 20 is sutured to the cloth cover 28. In particular,the leaflets 20 are sutured to the cloth cover 28 that covers the stentposts 24 such that each leaflet 20 extends between two of the stentposts 24. Each of the leaflets 20 is also sutured to the cloth cover 28covering the stent ring 22 between the two stent posts 24. The leaflets20 are made of a biological (e.g. porcine, pericardial, etc.) orsynthetic (e.g. polymeric) material and are configured to open and closeto regulate blood flow through the heart valve prosthesis 10 whenimplanted.

The sewing ring 16 is coupled to and extends around the stent ring 22opposite the stent post 24. The sewing ring 16 is formed of a tubularcloth covering 32, which is similar to the cloth covering 28 attached tothe stent 18. The cloth covering 32 is sutured to the cloth covering 28of the stent 18 about the outer perimeter of the stent ring 22 oppositethe extension of the stent posts 24.

In one embodiment, the pharmacological delivery implement 12 is encasedwithin the cloth covering 32 of the sewing ring 16. As best illustratedin FIG. 2 with additional reference to the cross-sectional FIGS. 2A and2B, the pharmacological delivery implement 12 includes a substantiallyannular, porous member 40 defining an outer surface 41 having an inflowside 42 and an outflow side 44. The annular porous member 40 defines aporosity and a permeability great enough to allow blood flow through theannular porous member 40 from the inflow side 42 to the outflow side 44.

The annular porous member 40 further defines an internal channel 46 andat least one injection site 48. In one embodiment, the internal channel46 is formed as an annular lumen within annular porous member 40. Theinternal channel 46 is sized to receive and selectively maintain apharmacological agent 50, such as an anti-inflammatory drug, etc. Inparticular, the at least one injection site 48 is formed on the outersurface 41 of the annular porous member 40. In one embodiment, the atleast one injection site 48 is formed on the outflow side 44 of theannular porous member 40. The injection site 48 provides access from theouter surface 41 to the internal channel 46. In one embodiment, theannular porous member 40 defines at least two injection sites 48 tofacilitate proper injection of the pharmacological agent 50 within theinternal channel 46 without providing for escape of the pharmacologicalagent 50 from the release holes 52 or other injection sites 48. In oneembodiment, the annular porous member 40 includes two injection sites 48positioned opposite one another on the annular porous member 40.

In one embodiment, the annular porous member 40 defines a porosity and apermeability low enough to maintain the pharmacological agent 50 for adesired length of time (e.g., 2 hours, 2 weeks, or 2 months). Inparticular, in one embodiment, the annular porous member 40 has aporosity and permeability dependent upon the viscosity of thepharmacological agent 50 in order to selectively maintain thepharmacological agent 50 for a desired length of time. In oneembodiment, the annular porous member has a porosity and permeabilitydependent upon the elution profile of the pharmacological agent 50. Inaddition, in one embodiment, the porosity and permeability of theannular porous member 40 is determined at least in part by the expectedprotein growth upon the annular porous member 40 following implantation.

The annular porous member 40 further includes a plurality of releaseholes 52 extending from the outer surface 41 to the internal channel 46.In one embodiment, at least a portion of the plurality of release holes52 extend from the outflow side 44 of the outer surface 41 to theinternal channel 46. The release holes 52 are sized to allow escape ofthe pharmacological agent 50 from the internal channel 46 upon mixingwith blood, as will further be described below. In one embodiment, atleast a portion of the release holes 52 are inherently formed by theporosity of the annular porous member 40. In one embodiment, at least aportion of the release holes 52 are drilled, punched, or otherwiseformed and placed on the outer surface 41 in addition to the generalporosity of the annular porous member 40. In one embodiment, the annularporous member 40 is formed of an elastomeric polymer. In one embodiment,the annular porous member 40 is formed of silicone.

As shown in FIGS. 1 and 3, annular porous member 40 is embedded withinthe cloth cover 32 of the sewing ring 16. In one embodiment, the sewingring 16 further includes biocompatible cushion or stuffing material (notshown) disposed within the tubular cloth covering 32 along side thepharmacological delivery implement 12. In one embodiment, the sewingring 16 may further include an additional support ring (not shown)disposed within the cloth cover 32 to provide additional support to theheart valve prosthesis 10.

During use, a medical team member (not shown) accesses the heart valveprosthesis 10 including the pharmacological delivery implement 12. Inone embodiment, accessing the heart valve prosthesis 10 includesremoving the heart valve prosthesis 10 from a glutaraldehyde solution(not shown). Notably, the glutaraldehyde solution complicates storage ofthe pharmacological agent 50 within the porous member 40. Therefore,following removal of the heart valve prosthesis 10 from theglutaraldehyde solution, the medical team member injects thepharmacological agent 50 from needle 53 into the internal channel 46 viaat least one injection site 48. In one embodiment, in which the annularporous member 40 includes two injection sites 48, half of thepharmacological agent 50 is injected into the internal channel 46 viaone injection site, and the remaining half of the pharmacological agent50 is injected into the internal channel 46 via the opposing injectionsite 48.

Following injection, the pharmacological agent 50 is maintained withinthe internal channel 46. With this is mind, the viscosity of thepharmacological agent 50 and the porosity and permeability of theannular porous member 40 are such that the pharmacological agent 50 doesnot escape from the internal channel 46 prior to implantation within aheart valve replacement patient (not shown). In one embodiment, thepharmacological agent 50 has a gel or paste form to further supportmaintenance of the pharmacological agent 50 within the internal channel46.

Upon injection of the pharmacological agent 50 into the internal channel46, the heart valve prosthesis 10 is implanted into a patient's heart(not shown). In particular, the heart valve prosthesis 10 isintra-annularly or supra-annularly implanted and attached to the heartvalve annulus 30. In particular, in one embodiment, an inflow side 54 ofthe sewing ring 16 is placed to abut the heart valve annulus 30. Thesewing ring 16 is subsequently sutured to the heart valve annulus 30.

Following suturing of the heart valve prosthesis 10 to the heart valveannulus 30, the heart is reactivated and the patient is closed. Duringuse of the heart including the heart valve prosthesis 10, blood flow,generally indicated in FIG. 3 by arrows 60, flows through the heartvalve opening (not shown) and the valve body 14 of the heart valveprosthesis 10.

As blood periodically flows through the valve body 14, pressuresurrounding the heart valve eventually causes the sewing ring 16 to bepartially penetrated by blood. Blood moving through the sewing ring alsopenetrates the annular porous member 40 and mixes with thepharmacological agent 50 maintained within the internal channel 46 ofthe delivery vehicle 12. Blood mixing with the pharmacological agent 50continues to move through and out the annular porous member 40, inparticular, the release holes 52 and through the cloth covering 32. Assuch, the pharmacological agent 50 is transported out of the internalchannel 46, gradually exiting the release holes 52, and contacting thesurrounding heart valve annulus tissue 30. Interaction between thepharmacological agent 50 and the annulus tissue 30 permit thepharmacological agent 50 to treat and decrease inflammation of, and/orscar tissue growth on the annulus tissue 30 and other surroundingcardiac tissue.

Alternatively, or in addition to the transportation of thepharmacological agent 50 via blood flow 60, the pharmacological agent 50is transported out of the internal channel 46 by general diffusion. Inparticular, general patient movement (whether internal and/or external)gradually causes the pharmacological agent 50 to exit the release holes52 to interact with the surrounding heart tissue. As described above,interaction between the pharmacological agent 50 and the annulus tissue30 permit the pharmacological agent 50 to treat and decreaseinflammation of, and/or scar tissue growth on the annulus tissue 30 andother surrounding cardiac tissue.

FIG. 4 illustrates another embodiment of a heart valve prosthesis 70, inwhich the heart valve prosthesis 70 is a mechanical heart valve. Theheart valve prosthesis 70 includes a valve body 72 and a sewing ring 74.The valve body 72 includes an annular housing 76 and rigid leaflets 78.The annular housing 76 is rigid and substantially hollow. The rigidleaflets 78 are attached within the annular housing 76 in a rotatable orpivotable fashion to open and close the annular housing 76. The sewingring 74 extends from one edge of the annular housing 76 in a similarmanner as described with respect to the stent ring 22 above. The sewingring 74 is substantially similar to the sewing ring 16, and as such,includes a pharmacological delivery implement 12 also described above.

The heart valve prosthesis 70 is used and functions in a similar manneras described above with respect to the heart valve prosthesis 10.Notably, however, the mechanical heart valve prosthesis 70 is not storedin glutaraldehyde solution. Therefore, in one embodiment, thepharmacological agent 50 is injected into pharmacological deliveryimplement 12 prior to storing the mechanical heart valve prosthesis forsubsequent implantation.

FIGS. 5 and 5A illustrate one embodiment of an annuloplasty prosthesis80. In one embodiment, the annuloplasty prosthesis 80 is an annuloplastyband. The annuloplasty prosthesis 80 includes the pharmacologicaldelivery implement 82 extending in an arcuate manner and a cloth coveror sheath 84 enclosing the pharmacological delivery implement 82.

The pharmacological delivery implement 82 includes a porous member 86which not only forms a portion of pharmacological delivery implement 82but also provides shape, stiffness, and support to the annuloplastyprosthesis 80. In particular, the porous member 86 is a generallyarcuate member encompassed within the cloth sheath 84. The porous member86 extends from a first end 88 to a second end 90. In one embodiment,each end 88 and 90 defines an eyelet or an opening (not shown) withsubstantially closed perimeter but does not require a specific shape(e.g. an eyelet can be round, square, rectangular, trapezoidal,hexagonal, tear-drop, oval, elliptical or any other suitable shape,although shapes with lower stress concentration and rounded features aregenerally preferred). Each of the eyelets are adapted to receive atleast one suture (not shown) to secure the annuloplasty prosthesis 80 toa heart valve annulus 30 (FIG. 6) of a heart valve.

Other features of the pharmacological delivery implement 82 are similarto the features described with respect to the pharmacological deliveryimplement 12 described above. With this in mind, pharmacologicaldelivery implement 82 similarly defines an internal channel 96, at leastone injection site 98 (FIG. 5A), and a plurality of release holes (notshown).

In one embodiment, pharmacological delivery implement 82 additionallyincludes an optional metallic wire 100 extending throughout the internalchannel 96. The metallic wire 100 provides additional stiffness andsupport to the annuloplasty prosthesis 80. In one embodiment, themetallic wire 100 is formed of a biocompatible metal, such as nitinol ora cobalt alloy (e.g., MP35N® made from cobalt-35, nickel-20,chromium-10, and molybdenum and manufactured by SPS Technologies, Inc.of Jenkintown, Pa.). In an alternate embodiment, as illustrated in thecross-sectional view of FIG. 5B, the metallic wire 100 extends throughthe internal channel 96 and is anchored to an internal surface 99 of theporous member 86. In one embodiment, the porous member 86 optionallyforms an extension as generally indicated by the hidden lines 101encompassing the metallic wire 100 and, thereby, maintaining metallicwire 100 in a static position with respect to the remainder of theporous member 86. Notably, the positioning of the metallic wire 100 doesnot block the path of the injection hole 98 to the internal channel 96.

The pharmacological agent 50 is injected through the injection site 98into the internal channel 96. In one embodiment, the pharmacologicalagent 50 is injected into the internal channel 96 prior to storing thepharmacological delivery implement 82 for subsequent use. In oneembodiment, the pharmacological agent 50 is injected into the internalchannel 96 just prior to implantation.

With additional reference to FIG. 6, the annuloplasty prosthesis 80filled with the pharmacological agent 50 is subsequently implanted intoa heart (not shown), more particularly to a heart valve annulus 30 abouta heart valve 102. More specifically, the annuloplasty prosthesis 80 issutured to and supports a posterior portion 104 of the heart valveannulus 30. With this in mind, the annuloplasty prosthesis 80 does notextend across an anterior portion 106 of the heart valve annulus 30.

Following implantation, during use of the heart, blood flows through theheart valve 102. As the blood surrounds and moves past the annuloplastyprosthesis 80, blood gradually penetrates the cloth sheath 84 and thepharmacological delivery implement 82 to interact with thepharmacological agent 50. As additional blood penetrates theannuloplasty prosthesis 80 and blood escapes the annuloplasty prosthesis80, the blood moving through the annuloplasty prosthesis 80 mixes withthe pharmacological agent 50 and releases the pharmacological agent 50from the pharmacological delivery implement 82 and from the annuloplastyprosthesis 80. In particular, as the blood moves through theannuloplasty prosthesis 80, the blood and the pharmacological agent 50gradually exits the annuloplasty prosthesis 80, namely through theplurality of release holes (not shown). The blood mixed withpharmacological agent 50 escaping the annuloplasty prosthesis 80contacts the surrounding heart tissue (not shown), thereby, deliveringthe pharmacological agent 50 to the surrounding heart tissue to treatand decrease inflammation, scar tissue growth, stenosis, and otherundesired conditions.

Alternatively, or in addition to the transportation of thepharmacological agent 50 via blood flow, the pharmacological agent 50 istransported out of the internal channel 96 by general diffusion. Inparticular, general patient movement (whether internal and/or external)gradually causes the pharmacological agent 50 to exit the release holes(not shown) to interact with the surrounding heart tissue (not shown).As described above, interaction between the pharmacological agent 50 andthe annulus tissue 30 permit the pharmacological agent 50 to treat anddecrease inflammation of, and/or scar tissue growth on the annulustissue 30 and other surrounding cardiac tissue.

FIG. 7 illustrates another embodiment of annuloplasty prosthesis 80′ inwhich the annuloplasty prosthesis 80′ is an annuloplasty ring. Theannuloplasty ring 80′ is formed and includes a pharmacological deliveryimplement 82′ in a similar manner as described above with theannuloplasty prosthesis 80 and pharmacological delivery implement 82.The only difference between the annuloplasty prosthesis 80′ and theannuloplasty prosthesis 80 is that the pharmacological deliveryimplement 82′ including a porous member 86′ and the cloth sheath 84′each form a closed annular or D-shaped annuloplasty prosthesis 80′rather than a partially annular or merely arcuate annuloplastyprosthesis 80.

An internal channel 96′ is formed within and runs throughout the porousmember 86′. In one embodiment, the pharmacological delivery implement82′ further includes a metallic wire 100′, similar to the metallic wire100, encompassed by and extending throughout the entire annular orD-shaped porous member 86′. The metallic wire 100′ adds rigidity andstrength to the annuloplasty prosthesis 80′. With this in mind, theannuloplasty prosthesis 80′ functions in a similar manner as describedabove with respect to the annuloplasty prosthesis 80. However, uponimplantation, the annuloplasty prosthesis 80′ extends along both theposterior portion 106 (FIG. 6) and the anterior portion 108 (FIG. 6) ofthe heart valve annulus 30 (FIG. 6).

FIG. 8 illustrates another embodiment of an annuloplasty prosthesis 80″in which the annuloplasty prosthesis 80″ is an annuloplasty ring. Theannuloplasty ring 80″ is formed and includes a pharmacological deliveryimplement 82″ in a similar manner as described above with respect to theannuloplasty prosthesis 80′ including a pharmacological deliveryimplement 82′. With this is mind, the pharmacological delivery implement82″ is encompassed within a cloth sheath 84′. The pharmacologicaldelivery implement 82″ includes a porous member 86″ forming an internalchannel 96′.

The pharmacological delivery implement 82″ further includes a metallicwire 100″, similar to the metallic wire 100′, encompassed by andextending throughout a portion of the annular or D-shaped porous member86″. In particular, the metallic wire 100″ extends throughout theportion of the annuloplasty prosthesis 80″ corresponding with theposterior portion 106 (FIG. 6) of the heart valve annulus 30 (FIG. 6)but does not extend through the portion of the annuloplasty prosthesis80″ corresponding with the anterior portion 108 (FIG. 6) of the heartvalve annulus 30. As such, the metallic wire 100″ only adds rigidity andstrength to the posterior portion 108 of the annuloplasty prosthesis80″. As such, upon implantation, the annuloplasty prosthesis 80″ addsrigidity to both the posterior portion 106 and to a lesser degreesupports the anterior portion 108 of heart valve annulus 30. In otherrespects, the annuloplasty prosthesis 80″ functions in a similar manneras described above with respect to the annuloplasty prosthesis 80 and80′.

In general, a cardiac repair device (e.g., a prosthetic heart valve, anannuloplasty prosthesis, a vascular graft, etc.) including apharmacological delivery implement according to the present inventionallows pharmacological agents to be delivered to the heart or vascularmember to which the cardiac repair device is attached. Delivery of apharmacological agent to the heart or vascular member prevents ordecreases the occurrence of excess inflammation, excess scar tissuegrowth, stenosis, and regurgitation. By reducing inflammation, scartissue growth, stenosis, and regurgitation, use of the pharmacologicaldelivery implement decreases the number of cases in which extraction ofthe previously implanted cardiac repair device is necessary as well asthe emergency cases in which extraction of such a cardiac repair devicecannot be performed prior to excessive inflammation, scar tissue growth,stenosis, or regurgitation causing dire consequences.

As such, use of the pharmacological delivery agent within the cardiacrepair device as described above, prevents or decreases dangers inherentin stenosis and regurgitation as well as dangers associated withadditional patient surgery, such as anesthesia, infection, additionalheart stoppage time, blood loss, etc. As such, providing thepharmacological agent to the heart or vascular tissue decreases overallcomplications associated with cardiac repair as well as contributing tothe overall well being of the patient.

Although the present invention has been described with reference topreferred embodiments, workers skilled in the art will recognize thatchanges can be made in form and detail without departing from the spiritand scope of the present invention.

1. An annuloplasty prosthesis for implantation comprising: apharmacological delivery implement including an annular porous memberformed of a porous material defining pores, the porous member defining:an outer surface having an inflow side and an outflow side opposite theinflow side; and an internal channel consisting essentially of anunfilled annular lumen configured to selectively maintain an injectablepharmacological agent, wherein the outflow side of the porous memberincludes a plurality of release holes, in addition to the pores in themember, each of the release holes extending from the outer surface tothe internal channel and at least one injection site defined by theouter surface, wherein the release holes are sized to allow the releaseof the pharmacological agent, and a size of the release holes is greaterthan a size of the pores, wherein the pores are located on the inflowand outflow sides, wherein the release holes do not extend to the inflowside, wherein the at least one injection site provides access to theinternal channel from the outer surface for injecting thepharmacological agent into the internal channel, and wherein the porousmember is formed of silicone or an elastomeric polymer.
 2. Theprosthesis of claim 1, wherein the porous member has a porosity lowenough to maintain the pharmacological agent.
 3. The prosthesis of claim1, wherein the porous member has a porosity relative to a viscosity ofthe pharmacological agent to maintain at least a portion of thepharmacological agent within the internal channel for a desired timeperiod.
 4. The prosthesis of claim 1, wherein the porous member has aporosity relative to an elution profile of the pharmacological agent tomaintain at least a portion of the pharmacological agent within theinternal channel for a desired time period.
 5. An annuloplastyprosthesis for implantation comprising: an arcuate porous member formedof a porous material defining pores, the porous member defining an outersurface having an inflow side and an outflow side opposite the inflowside, the member comprising an internal channel consisting essentiallyof an annular lumen configured to selectively maintain an injectablepharmacological agent, wherein the outflow side includes a plurality ofrelease holes, in addition to the pores of the member, each of therelease holes extending from the outer surface to the internal channel,wherein the release holes are sized to allow the release of thepharmacological agent, and a size of the release holes is greater than asize of the pores, wherein the pores are located on the inflow andoutflow sides, wherein the release holes do not extend to the inflowside, and at least one injection site defined by the outer surface thatprovides access to the internal channel from the outer surface forinjecting the pharmacological agent into the internal channel; and afabric sheath encompassing the porous member.
 6. The prosthesis of claim5, wherein the porous member has a porosity low enough to maintain thepharmacological agent.
 7. The prosthesis of claim 5, wherein the porousmember has a porosity relative to the viscosity of the pharmacologicalagent to maintain at least a portion of the pharmacological agent withinthe internal channel for a desired time period.
 8. The prosthesis ofclaim 5, wherein the porous member has a porosity relative to an elutionprofile of the pharmacological agent to maintain at least a portion ofthe pharmacological agent within the internal channel for a desired timeperiod.
 9. The prosthesis of claim 5, wherein the prosthesis is anannuloplasty band.
 10. The prosthesis of claim 5, wherein the prosthesisis an annuloplasty ring.
 11. The prosthesis of claim 5, wherein apharmacological agent is maintained within the internal channel in aflowable state.
 12. The prosthesis of claim 5, wherein the prosthesis ischaracterized by the absence of a valve structure.
 13. A method ofdelivering a pharmacological agent to cardiac tissue, the methodcomprising: receiving an unfilled annular lumen disposed within anannuloplasty prosthesis having an annular porous member, wherein thelumen is configured to selectively maintain a pharmacological agent; theannular porous member formed of a porous material defining pores, theporous member defining: an internal channel and an outer surface, saidouter surface having an inflow side and an outflow side opposite theinflow side, wherein the outflow side includes a plurality of releaseholes, in addition to the pores in the member, each of the release holesextending from the outer surface to the internal channel and at leastone injection site extending from the outer surface to the internalchannel, wherein the release holes are sized to allow the release of thepharmacological agent, and a size of the release holes is greater than asize of the pores, wherein the pores are located on the inflow andoutflow sides, wherein the release holes do not extend to the inflowside; and implanting the prosthesis, filled by injecting apharmacological agent via the at least one injection site, within acardiac system; wherein upon functioning of the cardiac system, at leasta portion of the pharmacological agent exits the internal channel viathe plurality of release holes.
 14. The method of claim 13, furthercomprising: storing the prosthesis prior to injecting thepharmacological agent, which in turn occurs prior to implanting theprosthesis.
 15. The method of claim 13, further comprising: injectingthe pharmacological agent prior to storing the prosthesis.
 16. Themethod of claim 13, wherein, upon functioning of the cardiac system,fluid flow from the inflow side to the outflow side of the outer surfacefacilitates the exit of at least a portion of the pharmacological agentfrom the internal channel.
 17. An annuloplasty prosthesis comprising: anarcuate porous member formed of a porous material defining pores, theporous member defining: an outer surface having an inflow side and anoutflow side opposite the inflow side, an internal channel configured toselectively maintain an injectable pharmacological agent, wherein theoutflow side includes a plurality of release holes, in addition to thepores in the member, each of the release holes extending from the outersurface to the internal channel wherein the release holes are sized toallow the release of the pharmacological agent, and a size of therelease holes is greater than a size of the pores, wherein the pores arelocated on the inflow and outflow sides, wherein the release holes donot extend to the inflow side, and at least one injection site providingaccess to the internal channel from the outer surface for injecting thepharmacological agent into the internal channel; a fabric sheathencompassing the porous member; and a pharmacologic agent selectivelymaintained within the internal channel.